Study Start Up

Because of the complexity of new study submissions, and the various review processes determining they may undergo, Protocol Review Coordinators (PRCs) are trained to assist study teams in identifying the appropriate review process, identifying the necessary forms, and planning a timeline for review.

Protocol Review Coordinators can provide an email tailored to the type of study being submitted. This email includes links to forms and specific information needed to begin the process.

Below you will find documents describing the process for new submissions based on the type of study (intervention or non-intervention) and the origin of the study (Fred Hutch Clinical Research Division, UW Cancer Consortium, etc.).

Additionally, you will find more information for each step in the process on the following pages:

Interventional Research / Expanded Access INDs

Use for a protocol regulated by the Food and Drug Administration that allows physicians to provide treatment with an investigational new drug to a patient with a serious disease or condition who cannot participate in a clinical trial.